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ME and JR designed the questionnaires, coordinated trial field-work, acquisition of data and follow-up.
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ITR is non executive director of the North Wales Clinical Trials Unit which will coordinate trial management and scrutiny.
Our pilot has also demonstrated feasibility through our ability to recruit patients efficiently; investigator compliance with key aspects of the protocol; maintenance of data quality; maintenance of high follow-up rates; and the research team's ability to organize and coordinate trial procedures in a multinational trial.
The logistical problems relate to the rapid identification of the extra resources required to allow continued excellence in day-to-day management and monitoring of trial governance (both in participating centres and in coordinating trials units).
JR participates in the trial and coordinates the trial at GGz inGeest and coauthored this article.
NB included part of the patients and coordinated the trial.
FS coordinated the trial and is responsible for data acquisition.
SH coordinated the trial, conducted data collection and had input into the manuscript.
IvdA-S assisted in the design and coordinated the trial set-up.
In addition CC coordinated the trial and the collection of data.
TF recruited all participants, coordinated the trial, collected, and analysed all data.
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CEO of Professional Science Editing for Scientists @ prosciediting.com